Department of Breast Surgery, National Cancer Center Hospital, 1-1 Tsukiji 5-chome, Chuo-ku, Tokyo, Japan.
Breast. 2013 Jun;22(3):263-7. doi: 10.1016/j.breast.2013.03.002. Epub 2013 Apr 12.
The optimal treatment duration time and the causal relationship between neoadjuvant endocrine therapy and clinical response are not clear. Therefore, we conducted the present study to investigate the potential benefits of neoadjuvant exemestane therapy with the goal of identifying the optimal treatment duration.
This study was conducted at three hospitals, as a multicenter, randomized phase II trial(UMIN000005668) of pre-operative exemestane treatment in post-menopausal women with untreated primary breast cancer. Fifty-one post-menopausal women with ER-positive and/or PgR-positive invasive breast cancer were randomly assigned to exemestane for 4 months or 6 months. Clinical response, pathological response, and decisions regarding breast-conserving surgery were the main outcome measures.
Of the 52 patients that enrolled, 51 patients underwent surgery. Of those, 26 and 25 patients had been treated with exemestane for 4 and 6 months, respectively. Treatments were performed at 3 hospitals in Japan between April 2008 and August 2010. The response rates as assessed by clinical examination were 42.3% and 48.0% for 4 and 6 months of treatment, respectively. Pathological responses (minimal response or better) were observed in 19.2% and 32.0% of patients, and breast-conserving surgery was performed on 50.0% and 48.0% of patients from the 4 and 6 month treatment groups, respectively.
The results of this study demonstrate that responses were equal to 4 or 6 months of exemestane treatment. Therefore, we propose that the rates of breast-conserving surgery could be maximized by 4 months of treatment. Furthermore, in addition to using exemestane as a preoperative treatment in post-menopausal women with ER-positive breast cancer, we envision administering the drug over the long term under careful clinical supervision.
新辅助内分泌治疗的最佳治疗持续时间和因果关系尚不清楚。因此，我们进行了本研究，旨在探讨新辅助依西美坦治疗的潜在获益，并确定最佳治疗持续时间。
这是一项在三所医院进行的多中心、随机、Ⅱ期临床试验（UMIN000005668），纳入了未经治疗的原发性乳腺癌绝经后妇女，给予新辅助依西美坦治疗。51 例 ER 阳性和/或 PgR 阳性浸润性乳腺癌绝经后妇女被随机分配接受依西美坦治疗 4 个月或 6 个月。主要观察终点为临床缓解率、病理缓解率和保乳手术决策。
52 例入组患者中，51 例接受了手术。其中，26 例和 25 例患者分别接受了 4 个月和 6 个月的依西美坦治疗。研究于 2008 年 4 月至 2010 年 8 月在日本的 3 家医院进行。临床检查评估的缓解率分别为 4 个月和 6 个月治疗组的 42.3%和 48.0%。19.2%和 32.0%的患者出现了病理缓解（微小缓解或更好），4 个月和 6 个月治疗组分别有 50.0%和 48.0%的患者接受了保乳手术。
该研究结果表明，4 个月和 6 个月的依西美坦治疗缓解率相当。因此，我们建议 4 个月的治疗可使保乳手术的比例最大化。此外，我们设想除了在 ER 阳性乳腺癌的绝经后妇女中使用依西美坦作为术前治疗外，还可以在长期的临床监测下长期使用该药。
